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Open Access Study protocol

Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial

Nathan R Hill12, Daniel Lasserson12, Ben Thompson1, Rafael Perera-Salazar1, Jane Wolstenholme3, Peter Bower4, Thomas Blakeman4, David Fitzmaurice5, Paul Little6, Gene Feder7, Nadeem Qureshi8, Maarten Taal9, Jonathan Townend10, Charles Ferro10, Richard McManus1 and FD Richard Hobbs12*

Author Affiliations

1 Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK

2 NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Headley Way, Oxford OX3 9DU, UK

3 Department of Public Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF, UK

4 Centre for Primary Care, Institute of Population Health, University of Manchester, Williamson Building, Oxford Road, Manchester M13 9PL, UK

5 Primary Care Clinical Sciences, School of Health and Population Sciences, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK

6 Primary Medical Care, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton SO16 5ST, UK

7 School of Social and Community Medicine, University of Bristol, Office Room 1.01c, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK

8 School of Medicine, Room 1307 Tower Building, University Park, Nottingham NG7 2RD, UK

9 Department of Renal Medicine, Royal Derby Hospital, Uttoxeter Road, Derby, Derbyshire DE22 3NE, UK

10 Cardio-Renal Research Group, Departments of Cardiology and Nephrology, Queen Elizabeth Hospital Birmingham and University of Birmingham, Edgbaston, Birmingham B15 2TH, UK

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Trials 2014, 15:160  doi:10.1186/1745-6215-15-160

Published: 8 May 2014

Abstract

Background

Chronic kidney disease (CKD) is common and increasing in prevalence. Cardiovascular disease (CVD) is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway.

Methods

The study is a prospective randomised open blinded endpoint (PROBE) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30–44 mL/min/1.73 m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25 mg once daily in addition to routine care or routine care alone and followed-up for 36 months.

Discussion

BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of CVD) in patients with stage 3b CKD.

Trial registration

EudraCT: 2012-002672-13

ISRTN: ISRCTN44522369

Keywords:
Cardiovascular disease; Chronic kidney disease; CKD mortality; CKD aldosterone receptor antagonist